FDA 510(k) Application Details - K161707

Device Classification Name	Tester, Auditory Impedance   More FDA Info for this Device
510(K) Number	K161707
Device Name	Tester, Auditory Impedance
Applicant	GN OTOMETRICS Hoerskaetten 9 Taatrup DK-2630 DK Other 510(k) Applications for this Company
Contact	Asif Muhammad Other 510(k) Applications for this Contact
Regulation Number	874.1090   More FDA Info for this Regulation Number
Classification Product Code	ETY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2016
Decision Date	09/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review